http://www.jnj.com/connect/about-jnj/views-positions/sales

http://www.jnj.com/connect/about-jnj/views-positions/sales

Johnson & Johnson - Index

Johnson & Johnson - report - Index

Q:
Georgia, compliance is not new to the health
care industry; it is a highly regulated business.
Why is it a timely and important topic?
KERESTY: It’s important to first recognize that we have many
different compliance areas in the Pharmaceuticals Group.
We have Financial compliance. We have R&D compliance
for all of our pre-clinical and clinical studies. We have
Privacy compliance to ensure we protect not only our
employees, but also the patients who use our products. We
have compliance in the area that governs our dealings with
physicians, pharmacists and nurses. We have anti-corruption
compliance… so you see how diverse compliance is.
But today, we are seeing changing expectations in areas
where we have not historically received scrutiny. Recently,
health care companies have experienced external pressure
and review in areas where we have simply been accepted
and trusted in the past, for example, how we advertise and
promote our products.
This begins to challenge not only our current thinking,
but it also triggers a review of activities and practices that
were common many years ago, when they were accepted
as “industry standard”. We want
our compliance programs to
meet today’s standards but to also
remain competitive and ahead
of the curve on new thinking.
How does compliance
Q: intersect with
stakeholder engagement?
KERESTY: We take pride in our
relationships with external
regulators and other stakeholders.
A big contributor to the development
of our compliance programs
is the concept of partnership. This
means not looking at regulators
as police officers, but as thought
leaders who set broad standards
not only for our company,
but also for our industry, and
sometimes for the world. Our
engagement with these and other
PROFILES IN COMMITMENT
Georgia Keresty
Senior Vice President
Compliance
Pharmaceuticals Group
partners is critical. It gives Johnson & Johnson a seat at the
table when standards are shaped — and it gives us an opportunity
to show how we balance compliance with our business
objectives to succeed financially while bringing innovative
products to patients. A productive engagement with regulators
helps them to look at our industry, or even a particular
compliance discipline, in a well rounded, balanced way.
Q:
What are the compliance challenges in the
pharmaceutical sector?
KERESTY: Currently, we are facing a series of new challenges
in the pharmaceutical sales and marketing arena, notably the
standards for relationships with physicians and other health
care professionals. It is still an area that’s not well established;
the standards are evolving, as litigation makes its way
through the courts. To reinforce our commitment to compliance
and to address the expansion of laws that regulate the
marketing and promotion of health care products, the
Johnson & Johnson Law Department developed a series of
Health Care Regulatory Guidance Documents for Promotional
and Marketing Practices. These guidance documents help our
companies comply with fraud and abuse laws and handle
customer transactions and relationships appropriately. They can
be found on our website and are available to all employees.
Q:
“Accountability can’t sit in
an isolated corporate office.
It’s Company-wide, and
the personal responsibility
of every employee. For us
to perform well in every area
that is compliance-based,
every single person
has to understand how
to contribute to that
compliance performance.”
So, where does accountability for compliance lie?
KERESTY: Whether it’s a managing director, a sales representative,
a manufacturing operator or an information technology
programmer, everyone contributes to our compliance program.
We all need to know the rules and how our job affects
different compliance areas. There’s an understanding at
Johnson & Johnson that compliance with laws and regulations
isn’t divided into small factions. It doesn’t rest with the oversight
staff, with the EHS staff,
with the product quality staff,
with the privacy staff or with the
audit staff. Instead, it rests with
every single employee in the
Company. Accountability is part
of everyone’s day-to-day job,
regardless of his or her level and
regardless of his or her job.
If we do well as a Company,
that’s saying that everyone contributed
— but if we don’t do
well, it’s not as if blame can be
localized to one individual area.
Accountability can’t sit in an
isolated corporate office. It’s
Company-wide, and the personal
responsibility of every employee.
For us to perform well in every
area that is compliance-based,
every single person has to
understand how to contribute to
that compliance performance. �
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